OMEGA Diagnostics is moving closer to solving reliability issues with its highly anticipated HIV test but still cannot say when it will be commercially available.
The Alva company has been working on fixing the CD4 kit, which is able to identify when an HIV patient needs retroviral drugs without the need for a laboratory test, for several months.
In July it warned of a stability problem after five weeks stored at room temperature. However that is now believed to have been due to a degradation of raw material in just one batch.
Andrew Shepherd, chief executive, said: “We have now got six months stability at room temperature which proves we don’t have a systemic stability issue.”
Omega believes the cause of a separate ambient temperature issue, which it told the market about in October, has been identified and it is making progress on a “potential” fix.
Mr Shepherd said: “We still have to do a lot of work to prove that but we are quite confident we can do that with the level of resource we are putting into the problem.
“There is a large team on it now, including external consultants, so there is a lot of brain power in this investigative process. We believe it will come good.”
Mr Shepherd admitted it was “very difficult” to put a time on when the CD4 will be available for commercial launch but said the appetite among non-government organisations working in developing countries remains vast.
House broker Finncap said: “Once the company has a satisfactory design, the verification and validation process will re-commence.”
AIM-listed Omega recorded an eight per cent increase in revenue from £5.69m to £6.15m for the six months to September 30.
The food intolerance division was the strongest performer with a 20 per cent hike from £2.78m to £3.34m with its consumer Food Detective brand seeing growth across the European Union, Latin America and the Far East.
The infectious disease division saw revenue grow 13 per cent to £1.22m helped by new distributors in Africa and sales in the Middle East and UK.
The allergy and autoimmune arm continues to be impacted by changes in the German market where there is a lower reimbursement rate for certain tests which has led to smaller medical practices not carrying them out as often. Allergy sales dipped 18 per cent to £1.29m as they were also hit by currency fluctuation.
Pre-tax profit was down from £208,418 to £177,360 which the company said was partly down to investment in people and facilities in the period.
The group’s new 20,000 square feet manufacturing plant in Pune, India, is in the process of being commissioned and has secured a contract to make a malaria test.
Jag Grewal, sales and marketing director, said the 40 allergens Omega is working to optimise for its Allersys laboratory system will soon be CE marked. He hopes to have those available for commercial sale early in the company’s next financial year. So far 37 of the 40 proposed allergens, which cover 85 per cent of typical laboratory tests, are ready.
Mr Grewal confirmed a further eight are in the pipeline and there would be a “continual programme” of adding more allergens for the system.
Chief operating officer Colin King has been tasked with reviewing the group’s operations to come up with a plan for growth over the next three to five years.
He indicated Omega is well placed to expand in the area of gut health and also in regulated markets, such as the United States, although admitted this would “not happen overnight”.
He said: “I believe where we are today is at the bottom end of our growth curve. What we have are significant building blocks in place to accelerate growth.”
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